Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.

Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP [ Time Frame: Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pregnancy outcomes in HIV-1 uninfected women who choose to continue or discontinue FTC/TDF for PrEP during their pregnancy as well as HIV-infected women treated with antiretrovirals [ Time Frame: Years 1, 2, and 3 ] [ Designated as safety issue: No ]

The study has one target prospective cohort defined as HIV-1 negative women who had been prescribed FTC/TDF for pre-exposure prophylaxis (PrEP); with two strata: a) those who continue to take FTC/TDF for PrEP during their pregnancy, and b) those who decide to stop FTC/TDF for PrEP during pregnancy.

ARV population

The study has one comparison cohort defined as HIV-positive women who were on any antiretroviral (ARV) medication at the time the pregnancy was detected. This is a propensity score matched retrospective cohort selected from the prospective arm of the APR. This cohort is assembled retrospectively in order to appropriately match the subjects by calendar time and the correlates of exposure, with exposure being defined as being on FTC/TDF for PrEP vs being exposed to other ARVs.

Eligibility

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Number of Subjects and Subject Selection: 400 HIV-1 uninfected women who are exposed to FTC/TDF for PrEP during pregnancy stratified into 200 who decide to continue and 200 who choose to discontinue FTC/TDF for PrEP. A propensity score-matched comparison group of equal size (400 women) of HIV-positive pregnant women taking antiretrovirals.

All evaluable subjects enrolled into the APR who fulfill the inclusion criteria for the target cohort will be selected. Every year at the time of building the annual report for this study, a propensity score matched comparison group will be selected on a 1:1 ratio among all pregnant women on antiretrovirals.

Criteria

Common Inclusion Criteria

Pregnant women

Part of the prospective arm of the APR Target Group Inclusion Criteria

HIV-1 Negative

Choosing to remain on FTC/TDF for PrEP during pregnancy or,

Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria

HIV-1 Positive

On antiretroviral therapy

Exclusion Criteria:

This is an observational nested study and will monitor all reported exposures without intervention/exclusion.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865786